DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment filed on December 19, 2025 is acknowledged.
Claims 2, 5-7, 9, 12, 13, 17, and 20 have been canceled.
Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are pending and currently under consideration.
3. In view of applicant’s amendment, following rejections are set forth.
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161) in view of Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) as evidenced by the disclosure in the instant specification in page 78 that the heavy and light chain amino acid sequence of the anti-TNF antibody golimumab are SEQ ID NOs: 36 and 37, respectively, for the reasons of record.
Kavanaugh 1 teaches the intravenous administration of the anti-TNF antibody, golimumab, to patients with active psoriatic arthritis (Objective, left col in page 2151, Patients, left col in page 2152). Golimumab consists of a heavy chain amino acid sequence of instant application’s SEQ ID NO: 36 and a light chain amino acid sequence of instant application’s SEQ ID NO: 37 (see instant application’s page 78, example anti-TNF antibody sequences). Kavanaugh 1 further teaches that the anti-TNF antibody was administered at a dose of 2 mg/kg at weeks 0 and 4 and then every 8 weeks thereafter twice at weeks 12 and 20 with and without methotrexate (see entire document but specifically Patients and Methods, paragraph 2, page 2152). Patients were adults aged on average of 45.7 years old and 81.3% had greater than 3% body surface area involvement with psoriasis (Table 1). By week 24, 33.6% of patients achieved minimal disease activity, 76.8% achieved an ACR20 response, and 64.8% achieved a PASI75 response (Figure 3, Table 2).
The teachings of Kavanaugh 1 differ from the instant by disclosing administering the anti-TNF antibody every 8 weeks for 16 weeks but not every 8 weeks for at least 52 weeks, and Kavanaugh 1 also does not teach measuring whether the patient has achieved at week 52 a Disease Activity in PsA (DAPSA), a Dermatology Life Quality Index (DLQI), 75% improvement in Psoriasis Area and Severity Index (PASI), or a modified Nail Psoriasis Severity Index (mNAPSI).
Nevertheless, Kavanaugh 1 teaches that the study will be continue through 1 year which is 52 weeks.
Kavanaugh 2 teaches treating adult human patient with active PsA with subcutaneous injection of the same anti-TNF antibody at weeks 0, 4, 8, 12, 16, and 20 weeks and maintained subcutaneous injection every 4 weeks from week 24 on to week 52 (e.g. see Study Design in right col. in page 2505). Kavanaugh 2 teaches that administration maintaining once every 4 weeks onto week 52 ( 1 year) shows clinical efficacy including improvement in joint and skin responses and physical function maintained through 1 year and the frequency/types of adverse events were similar to those reported through week 24. (e.g. see Results in left col in page 2505). Kavanaugh 2 teaches that it was known that at week 24, subcutaneously administering anti-TNF antibody golimumab achieved ACR20, DAS28-CRP and PASI175 in significantly comared to placebo-treated patients. Kavanaugh 2 teaches that the rfficacy of golimumab in reducing signs and symptoms of PsA and improving physical function and quality of life was maintained at week 52 (e.g. see right col. in page 2515).
Regarding the measurements of the therapeutic effects at week 52 of treatment, Mease teaches measures of PsA include DAPSA, DLQI, PASI, mNAPSI, and DLQI (e.g. see page S64). Mease teaches that these measures assess joint inflammation and damage, enthesitis, dactylitis, skin and nail disease, spondylitis function, and quality of life, and allowing for more precise evaluation of disease activity and response to therapy with the goal of achieving remission or minimal disease activity (e.g. see left col. in page S83).
It would have been obvious to one of ordinary skill in the art to extend the administration of golimumab for 24 weeks to week 52 following every 8 weeks administration schedule, as taught by Kavanaugh 1, over 52 weeks because Kavanaugh 1 recommends a continuation of the trial over one year. In addition, since Kavanaugh 2 teaches the treatment of psoriatic arthritis by the administration of golimumab over one year following the once every 4 weeks original schedule and improvement of symptoms maintained over a year (week 52), it would also have been obvious to one of ordinary skill in the art to extend the intravenous administration schedule taught in Kavanaugh 1, namely administering 2 mg/kg every 8 weeks onto to the planted duration of week 52 with the expectation that, following the same administration of 2 mg/kg of intravenous golimumab for adult patients with over 3% body surface area involvement as taught in both Kavanaugh 1 and 2. An ordinary skill in the art would have been motivated to determine the therapeutic outcome following well-known protocols and clinical measurements DAPSA, DLQI, PASI, mNAPSI, and DLQI disclosed by Mease.
Therefore, Kavanaugh 1 when combined with Kavanaugh 2 and Mease would render the claims in the instant invention obvious to one of ordinary skill in the art. A person with ordinary skill in the art would have been motivated to combine both trials to continue the treatment for one year (52 weeks), and determine the therapeutic responses by following well established protocols to assess joint inflammation and damage, enthesitis, dactylitis, skin and nail disease spondylitis function and quality of life including DAPSA, DLQI, PASI, mNAPSI, and DLQI with a reasonable expectation of success.
Applicant’s arguments have been fully considered but have not been found persuasive.
Applicant argues that Kavanaugh 1 does not teach measuring efficacy by achieving scores such as a DAPSA score in the newly amended claims. Applicant asserts that Kavanaugh 2 teaches subcutaneously administering golimumab at a dose of 50 mg or 100 mg every 4 weeks and does not teach the anti-TNF antibody dosage of 2 mg/kg at week 0 and 4 then every 8 weeks for at least 52 weeks nor does it teach the clinical metrics. Applicant further argues that the cited prior art does not provide a reasonable expectation of success, because Kavanaugh 1 merely mentions continue through 1 year without specific teaching of dosing regimen and specific clinical metrics and Kavanaugh 2 does not teach the recited dosing regimen and clinical metrics after 1 year of treatment.
As such, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for following reasons:
Contrary to applicant’s reliance on newly added step of measuring whether the patient has achieved certain clinical metrics, e.g. DAPSA, note that these clinical metrics for evaluating therapeutic outcome of treating PsA were well known in the art at the time the invention was filed as disclosed in Mease.
Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Here, Kavanaugh 1 teaches method of treating human adult patients suffering from active PsA by IV administration of the same anti-TNF antibody golimumab at a dose of 2 mg/kg at week 0 and 4, followed by IV administration of the antibody every 8 weeks at week 12 and week 20 and achieved significantly greater improvements in signs and symptoms of PsA and less radiographic progression through week 24 (e.g. see Conclusion in right col. in page 2151). Based on these results, Kavanaugh 1 specifically concludes that the treatment should be continue for 1 year (52 weeks). An ordinary skill in the art would have been motivated by Kavanaugh 1 to continue IV administration every 8 weeks with a reasonable expectation of success because this would be the natural extension of the two IV administrations at week 12 (8 weeks from week 4) and at week 20.
In addition, Kavanaugh 2 teaches treating adult human patient with active PsA with subcutaneous injection of the same anti-TNF antibody at weeks 0, 4, 8, 12, 16, and 20 weeks and maintained subcutaneous injection every 4 weeks from week 24 on to week 52. Kavanaugh 2 designed subcutaneous injection of the same anti-TNF antibody with regiment followed week 20 onto week 52 (every 4 weeks administration).
Therefore, the instantly claimed method encompassing every 8 weeks thereafter for at least 52 weeks after week 4 treatment would have been obvious to one of ordinary skill in the art in the field of treating active PsA with the well-known anti-TNF antibody.
"[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Boesch, 617 F.2d at 276.
One of ordinary skill in the art would also be able to evaluate the outcome of the therapy by measuring the well-established clinical criteria for PsA including DAPSA, QLQI, PAS175, ACR20, mNAPSI score, and DLQI as taught by Mease and Kavanaugh 2.
Therefore, applicant’s arguments have not been found persuasive.
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,041,020 (the ‘020 patent) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161), Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85).
The instant claims are drawn to an intravenous administration of an anti-TNF antibody comprising SEQ ID NOs 36 and 37 heavy and light chain amino acid sequences for the treatment of psoriatic arthritis, wherein the antibody is administered at a dose of 2 mg/kg at week 0 and week 4, then every 8 weeks thereafter for at least 52 weeks, and wherein measuring whether the patient has achieved at 52 weeks of treatment at least one of the therapeutic metrices including DAPSA, PASDAS, MDA, VLDA, CDAI, DLQI, PASI, and ACR20.
Dependent claims 4 and 11 further limit the claim to patients with a greater than 3% body surface area psoriatic involvement at baseline. Dependent claims 14 and 18 further limit the claim to patients with greater than 18 years of age. Dependent claims 15 and 19 further limit the claims such that the administration additionally may comprise methotrexate.
The claims in the ‘020 patent recite a method of treating a TNF-α related condition, such as psoriatic arthritis, comprising the intravenous administration of an anti-TNF-α antibody with the heavy chain comprising SEQ ID NO: 36 and the light chain comprising SEQ ID NO: 37. Dependent claims 2 and 9 further limit the composition to 2 mg/kg at weeks 0 and 4 and then every 8 weeks thereafter. Dependents claim 3 and 10 further limit the claim such that the administration may additionally comprise methotrexate. The ‘020 patent also identifies SEQ ID NOs: 36 and 37 as the heavy and light chain of the antibody golimumab
The claims in the ‘020 patent differ from the instant invention by not reciting 52 weeks of treatment and measuring multiple patient assessment metrics after 52 weeks of treatment such as DAPSA, PASDAS, CDAI, VLDA, PASI90, PASI100, DLQI, and mNAPSI. The claims also differ by not reciting a patient age of greater than 18 years of age and a greater than 3% body surface area psoriatic involvement at baseline.
The teachings of Kavanaugh 1, Kavanaugh 2, and Mease have been discussed, supra.
Regarding patient age and body surface area psoriatic involvement at baseline, although the claims at issue are not identical, they are not patentably distinct from each other because, while the claims in the ‘020 patent do not recite patient age or body surface area psoriatic involvement, Kavanaugh 2 teaches the administration of golimumab at 2 mg/kg for adult patients aged on average 45.7 years and wherein 74% of them had a greater than 3% body surface area psoriatic involvement at baseline (Table 1).
It would thus be obvious to one of ordinary skill in the art to apply the golimumab administration with or without methotrexate recited in the ‘020 patent to patients aged on average 45.7 years with greater than 3% body surface area psoriatic involvement at baseline. A person with ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because the patient group described in Kavanaugh represent an administration target with a high chance of success.
Regarding 52 weeks of treatment, Kavanaugh 1 and 2 both teaches a 52-week clinical trial of golimumab in psoriatic arthritis (page 2505, Results). Although the reference is silent about the results after 52 weeks of treatment (e.g., the patients achieve low disease activity based on a Disease Activity in PsA (DAPSA) as recited in claims 1-12), it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art teachings. Given that the references when combined teach a method of treating the same PsA patients with the same anti-TNF antibody with identical amino acid sequences for the same duration of 52 weeks as the instant invention, it is reasonable to conclude that the prior art methods would inherently/intrinsically result in the same therapeutic outcomes, e.g., low disease activity based on ADPSA score encompassed in instant claims 1.
Regarding measuring whether the patients receiving treatment after week52 achieved the recited clinical metrics, note that an ordinary skill in the art would have following the well-documented evaluation of therapeutic effect of PsA as detailed in Mease to determine whether the anti-TNF antibody was effective
Therefore, Kavanaugh 1 and 2 in conjunction with Mease when combined with the ‘020 patent would render the claims in the instant invention obvious to one of ordinary skill in the art. A person with ordinary skill in the art would have been motivated to combine, and have a reasonable expectation of success, because applying the ‘020 invention over a longer period of time is an expected outcome for patients with psoriatic arthritis. Thus, the outcomes, when following the same treatment administration with or without methotrexate at 2 mg/kg for the patients described in Kavanaugh 1, Kavanaugh 2, and Mease will be the same between both the instant application and the ‘020 patent. Therefore, the claims in the ‘020 patent would render the instant claims obvious.
Applicant’s arguments and the Examiner’s rebuttals are essentially the same as discussed above.
9. Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US 12,122,824 (the ‘824 Patent, matured from USSN 17/320,490) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161), Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85).
The instant claims are drawn to an intravenous administration of an anti-TNF antibody comprising SEQ ID NOs 36 and 37 heavy and light chain amino acid sequences for the treatment of psoriatic arthritis, wherein the antibody is administered at a dose of 2 mg/kg at week 0 and week 4, then every 8 weeks thereafter for at least 52 weeks, and wherein measuring whether the patient has achieved at 52 weeks of treatment at least one of the therapeutic metrices including DAPSA, PASDAS, MDA, VLDA, CDAI, DLQI, PASI, and ACR20.
Dependent claims 4 and 11 further limit the claim to patients with a greater than 3% body surface area psoriatic involvement at baseline. Dependent claims 14 and 18 further limit the claim to patients with greater than 18 years of age. Dependent claims 15 and 19 further limit the claims such that the administration additionally may comprise methotrexate.
The claims in the ‘824 Patent are drawn to a method for treating a TNF-alpha related condition active PsA by administering an anti-TNF-alpha antibody via intravenous infusion at a dose of 2 mg/kg, at week 0, and 4, then every 8 weeks thereafter.
The claims in the ‘824 Patent differ from the instant claims by not reciting for treatment for at least 52 weeks and achieving multiple patient assessment metrics after 52 weeks of treatment such as DAPSA, PASDAS, CDAI, VLDA, PASI90, PASI100, DLQI, and mNAPSI. The claims also differ by not reciting a patient age of greater than 18 years of age and a greater than 3% body surface area psoriatic involvement at baseline.
The teachings of Kavanaugh 1 and 2 as well as Mease are described, supra.
Although the claims at issue are not identical, they are not patentably distinct from each other because, while the claims in the ‘824 patent do not recite patient age or body surface area psoriatic involvement, Kavanaugh 2 teaches the administration of golimumab at 2 mg/kg for adult patients aged on average 45.7 years and wherein 74% of them had a greater than 3% body surface area psoriatic involvement at baseline (Table 1).
It would thus be obvious to one of ordinary skill in the art to apply the golimumab administration with or without methotrexate recited in the ‘824 patent to patients aged on average 45.7 years with greater than 3% body surface area psoriatic involvement at baseline. A person with ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because the patient group described in Kavanaugh represent an administration target with a high chance of success.
Regarding 52 weeks of treatment, Kavanaugh 1 and 2 both teaches a 52-week clinical trial of golimumab in psoriatic arthritis (page 2505, Results). Although the reference is silent about the results after 52 weeks of treatment (e.g., the patients achieve low disease activity based on a Disease Activity in PsA (DAPSA) as recited in claims 1-12), it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art teachings. Given that the references when combined teach a method of treating the same PsA patients with the same anti-TNF antibody with identical amino acid sequences for the same duration of 52 weeks as the instant invention, and since the therapeutic metrics to evaluate treatment effect of PsA was well known as disclosed by Mease, it is reasonable to conclude that an ordinary skill in the art would have been motivated to extend intravenous administering anti-TNF antibody to PsA patients to week 52 and to evaluate the effect on the patients following well documented clinical metrics as disclosed by Mease.
Therefore, Kavanaugh 1 and 2 and Mease when combined with the ‘824 patent would render the claims in the instant invention obvious to one of ordinary skill in the art.
Applicant’s arguments and the Examiner’s rebuttal regarding the lack of recitation of the clinical metrics achieved at week 52 in the ‘824 Patent are essentially the same as discussed above.
10. Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over amended claims 1, 2, 4-9, and 11-14 of copending USSN 17/423,512 (the ‘512 application) in view of Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85).
The instant claims are drawn to an intravenous administration of an anti-TNF antibody comprising SEQ ID NOs 36 and 37 heavy and light chain amino acid sequences for the treatment of psoriatic arthritis, wherein the antibody is administered at a dose of 2 mg/kg at week 0 and week 4, then every 8 weeks thereafter for at least 52 weeks, and wherein measuring whether the patient has achieved at 52 weeks of treatment at least one of the therapeutic metrices including DAPSA, PASDAS, MDA, VLDA, CDAI, DLQI, PASI, and ACR20.
Dependent claims 4 and 11 further limit the claim to patients with a greater than 3% body surface area psoriatic involvement at baseline. Dependent claims 14 and 18 further limit the claim to patients with greater than 18 years of age. Dependent claims 15 and 19 further limit the claims such that the administration additionally may comprise methotrexate.
The amended claims in the ‘512 application are now drawn to a method comprising administering a composition comprising an anti-TNF antibody having a heavy chain of SEQ ID NO:36 and a light chain having SEQ ID NO:37 to a patient having active PsA via IV infusion at a dose of 2 mg/kg at weeks 0 and 4, then every 8 weeks thereafter and measuring whether the patient has achieved a signiant mean change form baseline in total modified van der _heijde Sharp (vdH-S) score including DAPSA. Dependent claim 12 further recited that the patient is 18 years of age of over and dependent claim 13 recites additional administration of MTX.
The claims in the ‘512 application differ from the instant claims by not reciting other clinical metrics such as DLQI, PASI, mNAPSI, and QLQI.
The teachings of Mease have been discussed above.
It would thus be obvious to one of ordinary skill in the art at the time the invention was filed to determine the therapeutic outcome by determining DAPSA and additional well known clinical metrics as disclosed in Mease including DLQI, PASI, mNAPSI, and QLQI. Therefore, the claims in the ‘512 application would render the instant claims obvious.
11. Claims 1, 3, 4, 8, 10, 11, 14-16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of copending Application No. 18/889,629 (the ‘629 application) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161) and Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85).
This is a provisional nonstatutory double patenting rejection.
Applicant’s arguments and the Examiner’s rebuttals are essentially the same as discussed above.
12. No claim is allowed.
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641